DCGI Approval From India

We assist in getting approval of FDCs from drug controller general of india and other pharma services like sales training,HR policy writing, product managment services, promotional strategy formulations.

Friday, July 2, 2010

1. Infection caused by ESBL (extended spectrum of betalactamse) producing bacteria can only be controlled by the combination of antibiotics.2. ESBL producing bacteria are P.aeruginosa, S.aurious,S.pneumonia,E.coli, and Mirabilis etc3. Moxifloxacin easily covers all bacteria except P.aeruginosa and Cefixime kills all bacteria except S.aurious.4. Therefore, the combination of moxifloxacin and cefixime can kill all ESBL producing bacteria in one go.5. Both the antibiotics can be given safely to impaired renal and liver patients and there will be no dosage adjustment required.6. Patent has already been filed in USFDA with all required data like moxifloxacin-cefixime structure, FIC(Fractional Inhibitory Concentration) value etc.7. The combination is synergistic rationale and there is no drug interaction among both the drugs.8. There is no photosensitiv reaction with moxifloxacin unlike other quinolones.9. The combination is once a day which will help to accept by the physicians and patients10. The combination offers ESBL coverage safely with convenient dosage schedule in an economical rate.

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Osteoarthritis (OA) is common in the elderly, and pain is a frequent symptom of OA. Nonsteroidal antiinflammatory drugs (NSAIDs) are often effective for the treatment of OA pain and are recommended by the AmericanCollege of Rheumatology 2000 guidelines. Despite chronic NSAID therapy, OA patients may experience acute painful flares, and breakthrough pain on NSAIDs is a common reason for seeking additional treatment.

The analgesic ceiling effect, at which efficacy plateaus despite increasing dose, and the risk of adverse events (e.g., gastrointestinal, cardiovascular, renal) can make increasing the NSAID dose inappropriate for the management of painful OA flare, especially in older patients who, for example, have 3% to 4% annual risk of gastrointestinal bleeding compared with about 1% risk for the general population. Additionally, the American College of Rheumatology 2000 guidelines recommend against the combined use of two NSAIDs, including cyclooxygenase (COX)-2-selective NSAIDs, for pain relief because of the increased risk for gastrointestinal and renal side effects

The use of combination therapy for the management of the pain associated with OA has been recommended to improve efficacy. Use of multiple analgesics, especially with different mechanisms of action and pharmacokinetics, can overcome the efficacy and safety limitations of the individual agents and can provide additive, or even synergistic, pain relief. The new American Pain Society 2002 guidelines for OA pain management specifically recommend the use of tramadol in combination with acetaminophen (APAP) at any time during treatment when NSAIDs alone provide inadequate pain relief.

In the dental acute pain model, the combination tramadol 37.5 mg/APAP 325 mg was shown to be more effective and have a faster onset of action (17 minutes) than tramadol (51 minutes) and longer duration of action (>5 hours) than either component alone (tramadol 2 hours, Paracetamol 3 hours), with no increase in adverse events. It is noteworthy that the combination of tramadol and paracetamol is also approved by DCGI.

A new semi-opioid analgesic with a dual mechanism of action has been released for market by PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Tapentadol is a mu-opioid receptor agonist as well as an inhibitor of norepinephrine reuptake. The drug was originally approved by the FDA last year. It is non another but tapentadol a novel, centrally acting analgesic with two mechanisms of action that confers broad efficacy, as demonstrated in a variety of preclinical analgesia models. The pharmacologic activity of tapentadol is due to both mu-opioid receptor (MOR) agonism and norepinephrine reuptake inhibition. Tapentadol has favorable side effect profile and rapid onset of action.

This novel analgesic, tapentadol is an attractive treatment option for the relief of moderate-to-severe acute pain, acute postoperative pain, osteoarthritis pain and/or low back pain, Whereas, Paracetamol is a widely used over-the-counteranalgesic (pain reliever) and antipyretic (fever reducer). It is commonly used for the relief of headaches. In combination with opioid analgesics, paracetamol could be used also in the management of more severe pain (such as in arthritis or advanced cancer). While generally safe for human use at recommended doses (1,000 mg per single dose and up to 4,000 mg per day for adults, up to 2,000 mg per day if drinking alcohol. Paracetamol is categorized as pregnancy category A by USFDA that mean it is completely safe drug.

The combination is recommended in mild hepatic impairement and geriatric patients and there is no need of dosage adjustment.

Therefore, the combination of tapentadol and paracetamol is better alternative in comparison to tramadol and paracetamol because efficacy and safety goes hand-in-hand with tapentadol and paracetamol combination to treat moderate to severe pain of osteoarthritis, toothache, and postoperative pain.

Like all functions in the body, the brain also depends on cellular energy. Simply put, the more efficiently brain cells can produce energy, the better the brain functions. As we age, energy productions in the body begin to decline. Energy production declines in the brain could be due to stress, drugs, immoderate alcohol consumption, lack of nutrients, poor circulation, or damage to brain cells due to pollutants. Aging also contributes to a decline in performance mainly due to the cumulative effect of these ravaging damages over a period of time.

The brain requires a consistent supply of nutrients to maintain performance efficiency. Scientists now believe that insufficiency in certain brain nutrients may lead to forgetfulness or momentary memory lapses. Two of these important brain nutrients come to us from the B vitamin family and form vital constituents of memory supplements.

Citicoline which is a form of the B vitamin choline found in all cells. Citicoline has been extensively studied and proven to benefit brain health. It supports brain functions and even ameliorates some of the cumulative damage that has ravaged the brain over a period of time. It plays a vital function in the formation of cell membranes. The brand Citicoline is known for its purity and consistency in quality.

Neurons or the brain cells found in the central nervous system are different from other cells in the body. Other cells in the body grow old, die and new ones are born to replace old ones. This is not so with neurons. Once neurons die, they are lost for good and can never be replaced. They however can be repaired and Citicoline plays a vital role in the repair of neurons.

At our birth we are endowed with 10 billion neurons. By the age of 22, your brain starts losing volume. You begin to lose one neuron a second. Cell to cell communication loses efficiency. This may lead to mis-mapping of information or even loss of information resulting in those “senior moments” so common to the elderly.

Aging also impairs membrane functions. Neuronal membranes have unique functions. They are conductors for transmitting nerve impulses. Citicoline supports energy production in the neurons. This in turn supports repair and maintenance of cell membranes, synthesis of brain chemicals, and propagation of electrical impulses—all necessary to support the broader functions of the brain such as memory, motor cognitive functions, thought and decision making processes. Supplementing your diet with memory supplements that contain Citicoline is an intelligent choice for those who would like to boost their mental energies and preserve memory and cognitive skills.

Another great ingredient to look for in a memory supplement is Vitamin B12. Vitamin B12 is the only B vitamin which is part mineral. It is called cobalmin and contains cobalt, a mineral that is known to stimulate red blood cell formation. One of the important roles of red blood cells is the transport of oxygen to various parts of the body. A deficiency in B12 leads to a deficiency in red blood cells and results in less oxygen supply to the entire body. Twenty percent of the body’s oxygen supply is required by the brain. And a lack of oxygen in the brain can starve neurons to death, leading to brain atrophy or shrinking of the brain which happens as we age.

B12 also helps to regulate the level of homocysteine (amino acid) in the body. Studies show that higher levels of homocysteines in the body are associated with a decline in memory and impaired cognitive abilities. B12 also helps in the maintenance and functions of neurons and is known to have neuron-protective properties.

B12 and Citicoline are called brain nutrients and should be included in any quality memory supplement. They help to sustain and promote the longevity of brain cells and inhibit their destruction due to aging.

Memory Matrix, a memory supplement, combines brain nutrients like Citicoline, and B12 with antioxidants. These ingredients in memory supplements work as neuro-protective agents. Phosphatidylserine, a memory supplement nutrient, is a phospholipid required to support neuronal membrane functions. These nutrients are considered to help boost memory, the production of brain energy, sustain cognitive and motor skills, and enhance focus and decision-making thought processes.

Generally, Myelin is made up of cholesterol, phosphatidyl choline complex. Myelin is the insulating layer which, along with fatty acids*, surrounds nerve fibres. This protects nerves just like the insulation arround electrical cables. In B12 deficiency, toxic 15-17 coal atom fatty acids have a demyelinating effect on nerves, and electrical impulse transmission is disturbed.

B12 is a vitamin required for blood formation and rapidly growing tissues. B12 is recognized as a factor in the synthesis of myelin. Methylcobalamin production requires cobalamin and is the cobalamin found in the central nervous system (CNS) and brain where it transports methyl groups (-CH3) to proteins in the myelin. It is for these reasons that B12 deficiency leads to anaemia (blood disorders include macrocytos and pernicious anaemia) and neurological disorders (Alzheimer's disease and suspected amalgam related disorders).

There are, as with many diseases, usually more than one factor which may be involved with causation. Given that the former disorders are rare, even in vegans who have low B12 intakes, what is more concerning is the potential for neurological disorders that may be subclinical. This occurs because it is possible to have a deficiency of B12 in the CNS even when blood levels of B12 are "normal", or what is called non-anaemic deficiencies. These occur for meat eaters with huge B12 intakes as well as for vegans. So laying the blame for neurological problems on veganism or indeed any alleged B12 intake deficiency is not always accurate, since increased B12 dietary intake will evidently, not always work. In these serious cases B12 is usually injected since dietary availability of B12 can be as low as 1% of the total ingested for mega B12 doses, and some patients do not convert dietary B12 to the methylcobalamin required for normal neurological activity so well.

Methylcobalamin is the active form of vitamin B12. It can easily enter into the cerebrospinal fluid of the brain whereas, Citicoline is a naturally occurring nontoxic and well-tolerated drug that is an essential intermediate for the synthesis of phosphatidylcholine, a major constituent of the gray matter of brain tissue

Justification of Rationale

Methylcobalamin is the active form of vitamin B12. It can easily enter into the cerebrospinal fluid of the brain. It is therapeutically used for the treatment of nerve degeneration and to treat metabolic induced disorders such diabetic neuropathy, diabetic gastropathy, glaucoma, male impotency, arthritis, hyperhomocysteinemia, sleep disturbances, arrhythmia,anorexia and anemia. Usual dose starts from 500 mcg and goes up to 6,000 mcg.

Whereas, Citicoline is a naturally occurring nontoxic and well-tolerated drug that is an essential intermediate for the synthesis of phosphatidylcholine, a major constituent of the gray matter of brain tissue. Citicoline promotes brain metabolism by enhancing the synthesis of acetylcholine and restoring phospholipids content in the brain. Citicoline is a used in pharmacotherapy of brain insufficiency and some other neurological disorders, such as stroke, brain trauma, and Parkinson's disease.

It can also cross blood-brain barrier and treats brain related disorders. It improves memory loss, concentration, learning ability, alertness, brain injury, Alzheimer's disease, headache, dizziness, and tinnitus, improves cognitive functions, glaucoma, Parkinson’s disease, Vascular Dementia. 500 mg per day might be the optimum citicoline dose and it can go up to 2,000 mg. It was concluded that citicoline modestly improves memory and behavioral outcomes. Both the salts separately prescribed by physicians, cardiologists, dialectologists, neurologists and general physicians.

The brain is the command center of the body. The brain has about 100 billion neurons that fire messages across trillions of microscopic gaps each moment of your life. It has more than 10 billion interlinked cells. It sends messages to, and receives stimulation from, all parts of the body. And the brain operates while you're sleeping or awake. So, it's no wonder the brain is probably the most nutritionally demanding organ in the body.

Memory loss is not inevitable. Many people believe that poor memory is a natural consequence of aging. However, if that were true, then why do we all know senior citizens who can still think as clearly as many younger people? And why are there senior citizens that are totally capable of living happy, healthy, independent lives? The answer is simple...significant memory loss is not necessarily a fundamental part of aging.

Keeps your brain functioning at its optimum level. Strong evidence suggests that those who take the most proactive stance on healthy nutrition typically enjoy greater physical and mental wellness. And therefore, many complementary alternative medical practitioners believe that supplement intervention with memory-specific nutrients; plus a healthy lifestyle, annual check-ups and regular physical and mental activities may support mental sharpness, speed, and flexibility well into the senior years.

Nutritional building blocks for healthy brain function. This combination is a physician formulated, science-based brain-health supplement designed to supply the essential vitamins, antioxidants and nutrients necessary to assist the body in supporting healthy memory, mood and motor functions. It nutritionally supports healthy brain oxygenation, blood flow, immune system defense, and cell membrane structure. In addition, it also nutritionally supports cell-to-cell communication which is crucial to healthy cognitive function.

Combination of methylcobalamin and citicoline could be the boon for the management for metabolic disorders, nerve rejuvenation and nerve regeneration by and large. The combination enters into the cerebrospinal fluid of the brain easily because it can cross the blood-brain barrier. The major indication of the combination could be diabetic neuropathy, glaucoma, diabetic gastropathy, memory loss, brain injury, anorexia, nerve rejuvenation, nerve regeneration and alertness.

Cefpodoxime is a oral third generation cephalosporin active against most of gram positive and gram negative bacteria except Pseudomonas, B. fragilis and Entrococcous. Clinical studies have confirmed efficacy of cefpodoxime in acute otitis media, sinusitis and tosillopharyngitis.

Once daily administration and safety profile increases compliance and decreases failure rate. It has a role as switch over therapy from intravenous ceftriaxone in serious respiratory tract infections (RTIs).

In areas where common respiratory pathogens show decreased sensitivity to penicillins and macrolides cefpodoxime can be used as empirical first line therapy in respiratory tract infections. It seems to be a promising molecule in pediatric typhoid fever because of its excellent activity against Salmonella species but clinical trials are limited.

Dosage is 8 mg/kg/day once for 5 days whereas co-amoxyclave is 40 mg/kg/day tds for 10-15 days. Tissue penetration of cefpodoxime is twice to that of Cefixime. Cefpodoxime is ten times more potent than cefixime against S.pneumonia. There is no dosage adjustment for liver failure patient unlike co-amoxyclave. There is no food drug interaction unlike co-amoxyclave.

Cephalosporin is the only antibiotic segment which is safe in pregnancy and lactation. It safe up to 3 months baby therefore used in pediatric Typhoid fever. Most admired antibiotic in the world in terms of efficacy and safety, 2005 Nov-Dec J Drug Dermatol

Cefpodoxime has more mileage in terms of efficacy, safetyand dosage convenience in comparison to other available treatment options..

The Cefpodoxime in sustain release would be boon for the medical fraternity in terms of convenient once a dose in treating spectrum betalactamase infection. This sustain release combination could be an economical for the patient and easy to prescribe the physician as well.